Home › Device types › KRL
Detector, Bubble, Cardiopulmonary Bypass
FDA product code KRL · Class 2 · Cardiovascular
8
Registered devices
148
Adverse events
4
Recalls
14
510(k) clearances
Devices with this code
Sarns™ Modular Perfusion System 8000 — Terumo Cardiovascular Systems CorporationSarns™ Modular Perfusion System 8000 — Terumo Cardiovascular Systems CorporationSarns™ Modular Perfusion System 8000 — Terumo Cardiovascular Systems CorporationCAPIOX — TERUMO CORPORATIONCAPIOX — TERUMO CORPORATIONSarns™ Modular Perfusion System 8000 — Terumo Cardiovascular Systems CorporationSarns™ Modular Perfusion System 8000 — Terumo Cardiovascular Systems CorporationSarns™ Modular Perfusion System 8000 — Terumo Cardiovascular Systems Corporation
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2010-10-15 | Terumo Cardiovascular Systems Corporation | Malfunction of the air bubble detection cable assembly causes a false air alarm or a check sensor message during system set-up. In some instances, users were no |
| 2007-09-19 | Terumo Cardiovascular Systems Corp | False Alarms: The air sensor may malfunction and trigger false alarms, and may continue to alarm thus preventing the device from being reset. |
| 2007-09-19 | Terumo Cardiovascular Systems Corp | False Alarm: The air sensor may malfunction and trigger false alarms, and may continue to alarm thus preventing the device from being reset. |
| 2007-09-19 | Terumo Cardiovascular Systems Corp | False Alarm: The air sensor may malfunction and trigger false alarms, and may continue to alarm thus preventing the device from being reset. |
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